Biotechnology Regulatory Authority of India Bill, 2013

House and Date of Introduction: Introduced in Lok Sabha on 22.04.2013

[Bill No. 57 of 2013]

Preamble

A

Bill

to promote the safe use of modern biotechnology by enhancing the effectiveness and efficiency of regulatory procedures and provide for establishment of the Biotechnology Regulatory Authority of India to regulate the research, transport, import, manufacture and use of organisms and products of modern biotechnology and for matters connected therewith or incidental thereto.

Whereas the modern biotechnology offers opportunities to address important needs related to agriculture, health, food production and environment;

And whereas India is a party to the United Nations Convention on Biological Diversity signed at Rio de Janeiro on the 5th day of June, 1992 which came into force on the 29th December, 1993; and Cartagena Protocol on Biosafety to the Convention which was adopted in Montreal on the 29th September, 2000 and came into force on the 11th September, 2003;

And whereas the aforesaid Convention and the Protocol provide that each Contracting Party shall, as far as possible and as appropriate, establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from modern biotechnology;

And whereas the Protocol provides that the Parties to the Protocol shall ensure that the development, handling, transport, use, transfer and release of any living modified organisms are undertaken in a manner that prevents or reduces the risks to biological diversity, taking also into account the risks involved to human health;

And whereas it is considered necessary to take measures for the safe and responsible use of biotechnology for safeguarding the health and safety of the people of India and to protect the environment and consolidate regulatory policies, rules and services under statutory and autonomous regulatory authority and also to strengthen the implementation of the aforesaid Convention and Protocol.

Be it enacted by Parliament in the Sixty-fourth Year of the Republic of India as follows:--

Chapter I

Preliminary

1 . Short title, extent and commencement.--

(1) This Act may be called the Biotechnology Regulatory Authority of India Act, 2013.

(2) It extends to the whole of India.

(3) It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint; and different dates may be appointed for different provisions of this Act and any reference in any provision to the commencement of this Act shall be construed as a reference to the coming into force of that provision.

(4) Any reference in this Act to a law which is not in force in the State of Jammu and Kashmir shall in relation to that State be construed as a reference to the corresponding law, if any, in that State.

2 . Declaration as to expediency of control by Union.--

It is hereby declared that it is expedient in the public interest that the Union should take under its control the regulation of organisms, products and processes of modern biotechnology industry.

3 . Definitions.--

In this Act, unless the context otherwise requires,--

(a) "animal clones" means animals derived through somatic cell nuclear transfer techniques excluding humans;

(b) "Appellate Tribunal" means the Biotechnology Regulatory Appellate Tribunal established under section 44;

(c) "Authority" means the Biotechnology Regulatory Authority of India established under sub-section (1) of section 4;

(d) "biotechnology" means modern biotechnology as defined under clause (r);

(e) "Chairperson" means the Chairperson of the Authority appointed under section 5;

(f) "Chief Regulatory Officer" means the head of a Division of the Authority under sub-section (3) of section 21;

(g) "clinical trial" means systematic study of any new organism or product specified in Schedule I in human for the purpose of generating data for discovering or verifying its clinical, pharmacological (including pharmacodynamic and pharmacokinetic) biological, or, adverse effects with the objective of determining safety, efficacy or tolerance of that organism or product;

(h) "confidential commercial information" means,--

(i) a trade secret or any other information which has a commercial or other value which would be, or could reasonably be expected to be, destroyed or diminished if such information was disclosed; or

(ii) such other information which relates to lawful commercial or financial affairs of a person, organisation or undertaking dealing with organisms or products specified under Part I or Part II or Part III of Schedule I which, if disclosed, could adversely affect such person, organisation or undertaking;

(i) "conjugation" means the union of gametes or unicellular organisms during fertilisation;

(j) "containment" means measures and protocols applied to limit contact of genetically engineered organisms or products with the environment external to the containment facility;

(k) "containment facility" means an enclosed structure with walls, floor and ceiling, or an area within such building, where containment is in accordance with the physical and operational requirements specified and regulated under clause (d) of sub-section (2) of section 18;

(l) "environment" shall have the meaning assigned to it in clause (a) of section 2 of the Environment (Protection) Act, 1986 (29 of 1986);

(m) "environmental release" means the use of genetically engineered organisms into the environment outside of any containment;

(n) "field trials" means a field experiment of growing a genetically engineered organism in the environment under specified terms and conditions which are intended to mitigate the establishment and spread of the organism;

(o) "import" means to bring into India the organisms and products of modern biotechnology by land, sea or air;

(p) "manufacture" means and includes the preparation, compounding, propagation, processing, or fabrication of any organism or product regulated under this Act;

(q) "Member" means a whole-time Member or part-time Member of the Authority appointed under section 5 and includes the Chairperson;

(r) "modern biotechnology" means the application of in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection but does not include tissue culture of unmodified plant cells; animal cell culture of unmodified gametes; and natural processes such as conjugation, transduction, transformation; polyploidy induction; and mutation breeding;

(s) "Monitoring Officer" means a person appointed as such under sub-section (1) of section 38;

(t) "mutation breeding" means a process which involves the use of ionizing radiation or chemical mutagenesis to induce mutations in the genome;

(u) "notification" means a notification published in the Official Gazette and the expression "notify" shall be construed accordingly;

(v) "organism" means any genetically engineered organism or living modified organism or genetically modified organism excluding humans, which is a product of modern biotechnology;

(w) "polyploidy induction" means the induction of a cell to have more than twice the basic or haploid number of chromosomes;

(x) "premises" means a building or structure or part of a building or structure or land;

(y) "prescribed" means prescribed by rules made by the Central Government under this Act;

(z) "regulations" means regulations made by the Authority under this Act;

(za) "Schedule" means Schedules I and II to this Act;

(zb) "State Government in relation to a Union territory" means the Administrator of that Union territory appointed by the President under article 239 of the Constitution;

(zc) "transduction" means natural transfer by means of a viral vector of a deoxyribonucleic acid sequence from one cell to another;

(zd) "transformation" means any reference to the natural transfer of genetic material from the donor to the recipient;

(ze) "University Grants Commission" means the University Grants Commission established under section 4 of the University Grants Commission Act, 1956 (3 of 1956);

(zf) "use" means authorisation of an organism or product regulated under this Act as safe for its intended purpose and such authorisation shall be subject to all other laws for the time being in force and rules and regulations made thereunder.

Chapter II

Biotechnology Regulatory Authority of India

4 . Establishment of Biotechnology Regulatory Authority of India.--

(1) The Central Government shall, by notification, establish an Authority to be known as the Biotechnology Regulatory Authority of India to exercise the powers conferred on it and to perform the functions assigned to it under this Act.

(2) The Authority shall be a body corporate, by the name aforesaid, having perpetual succession and a common seal with power to acquire, hold and dispose of properties, both movable and immovable, and to contract, and shall, by the said name, sue or be sued.

(3) The head office of the Authority shall be in the National Capital Region.

(4) The Authority may, with the prior approval of the Central Government, establish its offices at any other place in India.

5 . Composition of Authority.--

The Authority shall consist of a Chairperson and two whole time Members and two part-time Members to be appointed by the Central Government.

6 . Qualifications for appointment of Chairperson and Members.--

(1) The Chairperson of the Authority shall be a person of ability, integrity and outstanding scientific calibre with a doctorate degree or equivalent degree in the field of biological sciences or a postgraduate degree in medical sciences from a university recognised by the University Grants Commission or a university or institute...

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